Triple Negative Breast Cancer
Conditions
Brief summary
The study is being conducted to evaluate the tolerability, safety and efficacy of SHR-1210 in combination with Apatinib and Fluzoparib in subjects with recurrent and metastatic triple negative breast cancer
Detailed description
Drug: SHR-1210 + Apatinib +Fluzoparib SHR-1210 will be administered as an intravenous infusion, Apatinib tablets will be given orally, Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity. Treatment group ： PD-1 antibody SHR-1210 combination with apatinib and fluzoparib
Interventions
DRUGSHR-1210 + Apatinib +Fluzoparib
SHR-1210 will be administered as an intravenous infusion Apatinib tablets will be given orally Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Signed the informed consent. * Female aged ≥18 years old. * Histologically diagnosed patients with recurrent and metastatic triple negative breast cancer. * No more than 2-line chemotherapy failed at the stage of recurrence and metastasis . * Patients who have been treated with platinum-based regimen at the stage of recurrence/metastasis need non-disease progression (non-pd)during treatment * At least one measuring lesion that confirmed by RECIST v1.1 standard. * The patients can swallow pills. * Have a life expectancy of at least 12 weeks. * The functions of vital organs meet protocal requirements.
Exclusion criteria
* Subjects had any history of active autoimmune disease . * Subjects had previously been treated with anti-PD-1 and PD-L1 antibodies, or was known to be allergic to antibody drugs, or had previously been treated with apatinib, or had previously been treated with PARP inhibitors. * Subjects have untreated central nervous system metastasis. * History of hypertension and antihypertensive medications are not well controlled. * Some clinical symptoms or diseases of the heart that are not well controlled. * History of immunodeficiency including HIV-positive. * Subjects had active infections.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicity (DLT) | First cycle (28 days) | Dose Limiting Toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | up to 12 months (approx) from the start of treatment | — |
| Duration of response (DoR) | up to 12 months (approx) from the start of treatment | — |
| Adverse Events and Serious Adverse Events | from the first drug administration to within 90 days for the last SHR-1210 dose | AEs and SAEs |
| Progression-Free-Survival | up to 12 months (approx) from the start of treatment | PFS |
| 12-months overall survival rate | From the start of treatment to 1 year | 12-months overall survival rate |
| Disease Control Rate | up to 12 months (approx) from the start of treatment | DCR |
Countries
China
Outcome results
None listed